• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device implantable pacemaker pulse-generator
Product CodeDXY
Regulation Number 870.3610
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
19 23 20 14 19 0

MDR Year MDR Reports MDR Events
2019 1799 1799
2020 546 546
2021 560 560
2022 784 784
2023 946 946
2024 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1120 1120
Over-Sensing 470 470
Signal Artifact/Noise 389 389
Premature Discharge of Battery 313 313
Device Dislodged or Dislocated 298 298
Failure to Capture 270 270
High Capture Threshold 225 225
Pacemaker Found in Back-Up Mode 207 207
Failure to Interrogate 200 200
Pacing Problem 189 189
High impedance 184 184
Under-Sensing 159 159
Appropriate Term/Code Not Available 150 150
Impedance Problem 128 128
Inappropriate/Inadequate Shock/Stimulation 126 126
Device Sensing Problem 118 118
Fracture 113 113
Break 105 105
No Pacing 105 105
Capturing Problem 96 96
Low impedance 89 89
Data Problem 83 83
Incorrect Measurement 80 80
Insufficient Information 71 71
Failure to Disconnect 60 60
Decreased Sensitivity 57 57
Loose or Intermittent Connection 55 55
Mechanical Problem 51 51
Misconnection 50 50
Connection Problem 48 48
Defective Device 44 44
Battery Problem 44 44
Difficult to Remove 39 39
Positioning Problem 38 38
Incorrect, Inadequate or Imprecise Result or Readings 36 36
Electrical /Electronic Property Problem 34 34
Unstable Capture Threshold 31 31
Wireless Communication Problem 28 28
Intermittent Capture 27 27
Communication or Transmission Problem 26 26
Failure to Sense 25 25
Output Problem 24 24
Interrogation Problem 22 22
Inappropriate or Unexpected Reset 21 21
Electromagnetic Interference 20 20
Low Sensing Threshold 19 19
Use of Device Problem 18 18
Material Integrity Problem 16 16
Therapeutic or Diagnostic Output Failure 14 14
Pacing Asynchronously 13 13
Premature Elective Replacement Indicator 13 13
Telemetry Discrepancy 12 12
Difficult to Insert 12 12
No Apparent Adverse Event 12 12
Migration 11 11
Contamination of Device Ingredient or Reagent 11 11
Separation Failure 9 9
Activation, Positioning or Separation Problem 8 8
Display or Visual Feedback Problem 8 8
Retraction Problem 8 8
Inaccurate Synchronization 7 7
Therapy Delivered to Incorrect Body Area 7 7
Pacing Intermittently 7 7
Detachment of Device or Device Component 7 7
Fitting Problem 7 7
Reset Problem 7 7
Noise, Audible 7 7
Packaging Problem 6 6
Sensing Intermittently 6 6
Failure to Charge 6 6
Failure to Read Input Signal 5 5
Material Twisted/Bent 5 5
Device-Device Incompatibility 5 5
Battery Problem: High Impedance 5 5
Electromagnetic Compatibility Problem 4 4
Device Markings/Labelling Problem 4 4
High Sensing Threshold 4 4
Device Contamination with Body Fluid 4 4
Device Displays Incorrect Message 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Unauthorized Access to Computer System 4 4
Protective Measures Problem 4 4
Unable to Obtain Readings 4 4
Failure to Deliver Shock/Stimulation 4 4
Migration or Expulsion of Device 4 4
Nonstandard Device 3 3
Difficult or Delayed Positioning 3 3
Device Alarm System 3 3
Off-Label Use 3 3
Pacing Inadequately 3 3
Defibrillation/Stimulation Problem 3 3
Missing Test Results 3 3
Delayed Charge Time 3 3
Environmental Compatibility Problem 3 3
Malposition of Device 2 2
Failure to Advance 2 2
Component Missing 2 2
Device Handling Problem 2 2
Material Split, Cut or Torn 2 2
Patient Device Interaction Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1453 1453
No Known Impact Or Consequence To Patient 1276 1276
Unspecified Infection 697 697
Insufficient Information 196 196
No Consequences Or Impact To Patient 129 129
Death 123 123
Shock from Patient Lead(s) 108 108
Dizziness 82 82
Arrhythmia 80 80
Pocket Erosion 71 71
Syncope/Fainting 66 66
Discomfort 51 51
Syncope 51 51
Dyspnea 46 46
Bradycardia 39 39
Cardiac Arrest 35 35
Hematoma 35 35
Pericardial Effusion 35 35
No Information 34 34
Erosion 32 32
Sepsis 31 31
Cardiac Tamponade 31 31
Cardiac Perforation 29 29
Endocarditis 29 29
No Code Available 29 29
Pain 28 28
Undesired Nerve Stimulation 27 27
Tachycardia 27 27
Fatigue 26 26
Bacterial Infection 25 25
Chest Pain 25 25
Pneumothorax 23 23
Twiddlers Syndrome 23 23
Muscle Stimulation 21 21
Heart Failure/Congestive Heart Failure 20 20
Electric Shock 19 19
Ventricular Fibrillation 18 18
Swelling 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Wound Dehiscence 15 15
Atrial Fibrillation 15 15
Device Overstimulation of Tissue 14 14
Asystole 14 14
Tricuspid Valve Insufficiency/ Regurgitation 14 14
Fall 13 13
Stroke/CVA 12 12
Palpitations 12 12
Hemothorax 11 11
Low Blood Pressure/ Hypotension 11 11
Failure of Implant 10 10
Perforation 10 10
Vascular Dissection 10 10
No Patient Involvement 10 10
Thrombosis/Thrombus 10 10
Obstruction/Occlusion 9 9
Complaint, Ill-Defined 9 9
Hemorrhage/Bleeding 9 9
Fever 9 9
Purulent Discharge 9 9
Pulmonary Embolism 9 9
Pleural Effusion 8 8
Occlusion 8 8
Complete Heart Block 8 8
Heart Failure 8 8
Heart Block 8 8
Myocardial Infarction 7 7
Non specific EKG/ECG Changes 7 7
Edema 6 6
Twitching 6 6
Septic Shock 6 6
Foreign Body In Patient 6 6
Presyncope 6 6
Swelling/ Edema 6 6
Ventricular Tachycardia 5 5
Loss of consciousness 5 5
Post Operative Wound Infection 5 5
Inflammation 5 5
Hypersensitivity/Allergic reaction 5 5
High Blood Pressure/ Hypertension 4 4
Laceration(s) 4 4
Mitral Regurgitation 4 4
Abscess 4 4
Atrial Flutter 4 4
Malaise 4 4
Respiratory Failure 4 4
Pericarditis 4 4
Twiddlers Syndrome 4 4
Weakness 3 3
Burning Sensation 3 3
Great Vessel Perforation 3 3
Rupture 3 3
Cardiogenic Shock 3 3
Thrombosis 3 3
Cyanosis 3 3
Muscle Weakness 3 3
Foreign Body Reaction 3 3
Bone Fracture(s) 2 2
Headache 2 2
Fistula 2 2
Embolism 2 2

Recalls
Manufacturer Recall Class Date Posted
1 St. Jude Medical, Cardiac Rhythm Management Division II Aug-02-2022
-
-